FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1131041
·
Received August 20, 2008
Report
- Report Number
- 1644487-2008-01968
- Event Type
- Injury
- Date Received
- August 20, 2008
- Date of Event
- June 23, 2008
- Report Date
- July 21, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MFG RECORDS WERE REVIEWED. REVIEW OF MFG RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.
Description of Event or Problem · 1
REPORTER INDICATED A VNS PT UNDERWENT EXPLANT SURGERY DUE TO INFECTION. THERE ARE CURRENTLY NO PLANS FOR REPLACEMENT AT THIS POINT. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 200633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |